Compounding Pharmacist

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

3900 Duckhorn Dr, Sacramento, CA 95834

The Compounding Pharmacist at Nivagen will be responsible for leading the 503B outsourcing facility, ensuring adherence to compounding standards and regulatory compliance. This role is pivotal in meeting manufacturing and company goals by overseeing the successful operations of a fully compliant department. Key responsibilities include maintaining facility and equipment standards, ensuring safety, upholding product quality, optimizing manufacturing efficiency, and managing quality systems in line with regulatory requirements.

The Compounding Pharmacist will report directly to the CEO and/or the Production Manager.

• Work with Production Lead to achieve daily compounding output goals
• Design weekly production schedule with Production Lead
• Assign technician roles for the week (i.e. Mixer, Filler, Assistant, etc.)
• Direct techs to a particular task to maintain production flow
• Supervise compounding activities
• Perform Mixer, Filler, Assistant, or any technician duties as needed
• Check customer orders for accuracy
• Clinical customer service (Drug info, IV compatibility, osmolarity calculations etc.)
• Controlled substance records management
• QA reports/investigations as assigned: MOCA, CAPA, MRDD, Complaints
• Maintain team’s cGMP compliance at MSRX
• Participate in regulatory audits
• Draft SOPS revisions, process validation, draft a master compounding record, Process Validation etc
• Other duties as assigned by management or CEO and production manager

• Doctor of Pharmacy (Pharm.
  
  D.) degree from an accredited institution
• A minimum of two to three years of experience in a compounding pharmacy or a 503B outsourcing facility, or equivalent experience in related fields, is required

• Understanding and experience in USP 797 guidelines and manual aseptic manipulations
• Strong leadership skills with the ability to manage and mentor a team
• Excellent communication and organizational skills
• Experience with regulatory audits and inspections is a plus.
• Capable of maintaining confidentiality and handling sensitive information discreetly

• California Pharmacist License in good standing
• Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211
• Experience participating in a Manufacturing Unit in an FDA registered facility that includes cGMP compliance and sterile product preparation of pharmaceuticals OR experience as a pharmacist in a pharmacy that prepares sterile parenteral compounds
• Work in controlled environments and wear personal protective equipment as necessary
• Knowledge within the areas of quality control and process validation
• Familiarity and understanding of manufacturing methods related to quality control and quality assurance
• Experience participating in a supply chain management in an FDA approved GMP facility that includes cGMP…